Active ingredient: Flavoxate Hydrochloride

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Flavoxate Hydrochloride uses


INDICATIONS AND USAGE

Flavoxate Hydrochloride HCl tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate Hydrochloride HCl tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.

CONTRAINDICATIONS

Flavoxate Hydrochloride HCl tablets are contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

WARNINGS

Flavoxate Hydrochloride HCl should be given cautiously in patients with suspected glaucoma.

PRECAUTIONS

Information for Patients:

Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Flavoxate Hydrochloride HCl have not been performed.

Pregnancy:

Teratogenic Effects–Pregnancy Category B.

Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to Flavoxate Hydrochloride HCl. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Flavoxate Hydrochloride HCl is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children below the age of 12 years have not been established.

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ADVERSE REACTIONS

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Renal: Dysuria.

OVERDOSAGE

The oral LD50 for Flavoxate Hydrochloride HCl in rats is 4273 mg/kg. The oral LD50 for Flavoxate Hydrochloride HCl in mice is 1837 mg/kg.

It is not known whether Flavoxate Hydrochloride HCl is dialyzable.

DOSAGE AND ADMINISTRATION

Adults and children over 12 years of age:

One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.

HOW SUPPLIED

Flavoxate Hydrochloride HCl Tablets, 100 mg, are supplied as round, white, film-coated tablets debossed "PAD" and "0115" on one side and plain on the other side, in bottles of 100.

100 mg 100's:

NDC 0574-0115-01

Store at 20° to 25°C (68° to 77°F)

Manufactured For

Perrigo®

Minneapolis, MN 55427

Manufactured by:

Mikart, INC.

Atlanta, GA 30318

Code 917A00

7H700 RC J1

Rev 03-14 A

Flavoxate Hydrochloride available forms, composition, doses:


Indications and Usages:

ATC codes:


ICD-10 codes:


Flavoxate Hydrochloride destination | category:


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Drugs with same active ingredients (Pharmaceutical companies):


References

  1. Dailymed."FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "flavoxate". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "flavoxate". http://www.drugbank.ca/drugs/DB0114... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Flavoxate Hydrochloride?

Depending on the reaction of the Flavoxate Hydrochloride after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Flavoxate Hydrochloride not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Flavoxate Hydrochloride addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Flavoxate Hydrochloride, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Flavoxate Hydrochloride consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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